FDA UDI
In Commercial Distribution
🇺🇸 United States
SciPharm Anterior/Posterior Restoratives
DI: D801SP50041
·
Model: SP 50-04
·
SCIENTIFIC PHARMACEUTICALS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SciPharm Anterior/Posterior Restoratives
- Primary DI
- D801SP50041
- Version / Model
- SP 50-04
- Catalog Number
- 50-04
- Company Name
- SCIENTIFIC PHARMACEUTICALS, INC.
- Labeler DUNS
- 096010525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-05
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 675c7a0a-fec7-496e-84c5-bb62d4ce977e
Device Description
Visible Light-Cured, Highly Filled Composite Restorative For Use Primarily in Class I and Class II Restoratives.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EBD | Coating, Filling Material, Resin | Dental | 872.3310 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35870 | Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D801SP50041 | HIBCC |
Customer Contacts
- Phone
- 800-634-3047
- [email protected]
- Phone
- 909-595-9922
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K791078 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 73 Degrees Fahrenheit